Expiration date: 10/2025
Composition and form of issue:
Solution for infusion. 1 ml contains:
linezolid 2 mg
excipients: sodium citrate dihydrate citric acid anhydrous glucose monohydrate water for injection
in packs of infusion disposable 300 ml in a pack of cardboard 10 PCs.
Tablets, film-coated. 1 tablet contains:
linezolid 600 mg
excipients: corn starch MCC hydroxypropyl cellulose sodium salt glycolate starch magnesium stearate dye Opadry White Y-1-18202-a Carnauba wax red pharmaceutical ink Opacode Red FGE-15040
in contour cell pack 10 PCs. in a pack of cardboard 1 package.
Granules for preparation of suspension for oral administration. 5 ml contains:
the finished suspension (1 dose)
linezolid 100 mg
excipients (5 ml): sucrose citric acid sodium citrate microcrystalline and sodium salt of carboxymethylcellulose aspartame xanthan gum mannitol sodium benzoate, orange flavor, colloidal silicon dioxide, mint flavor S. D. F93125 vanilla flavoring sodium chloride sweetener Sweet-am 918/.005 sweetener Mafco Magnasweet 135 orange cream flavor
in bottles of dark glass 150 ml, complete with a measuring spoon in a pack of cardboard 1 set.
Description of dosage form:
Solution for infusion 2 mg/ml: clear, colorless or yellow isotonic solution.
Film-coated tablets, 600 mg each: white oval film-coated tablets.
Granules for preparation of suspension for oral administration 20 mg / ml: white or almost white, flavored (orange) granules for dissolution.
Method of application and doses:
Inside, in/V. of tablets, coated Tablets, or suspension can be taken with food or between meals. Solution for infusion should be administered within 30-120 min. Appointed in the recommended single dose 2 times a day.
Patients who started treatment with parenteral forms, according to clinical indications can be switched to any drug form for oral administration. In this case, no dose selection is required, because the bioavailability of linezolid when administered is almost 100%.
Adults (see table):
| Indications (including bacterial infections) | Single dose and method of administration | The recommended duration of treatment* |
| Outside of a hospital pneumonia | 600 mg in / in or inside | 10-14 days |
| Hospital-acquired pneumonia | ||
| Skin and soft tissue infections | 400-600 mg orally or 600 mg in/in depending on the severity of the disease | |
| Enterococcal infections | 600 mg in / in or inside | 14-28 days |
* The duration of treatment depends on the causative agent, the location and severity of the infection, as well as the clinical effect.
Children (5 years and older): the recommended dose is 10 mg/kg body weight 2 times a day inside. The maximum dose for adults and children should not exceed 600 mg twice a day.
Instructions for use.
Infusion solution: remove the protective foil from the foil immediately before use and for about 1 minute, squeeze the infusion bag to make sure there are no leaks. If the package is leaking, the solution is non-sterile!
Do not connect the infusion bags in series.
The remains of the unused solution should be poured into the waste. Do not use partially filled packaging.
Granules for the preparation of the suspension for oral administration: slightly knock on the bottle to the powder is spilled, accurately measure the measuring cylinder 123 ml of water and add to the bottle in 2 admission (2 approximately equal portions) to obtain 150 ml of the suspension. After adding the first portion of water should be strongly shake the bottle to well moisten the entire contents, then add the rest of the water and shake the bottle again to obtain a uniform suspension. Before use, the suspension should be resuspended, turning the bottle 3-5 times (do not shake!).
